Hi, this is Stuart Talley providing an update on the DePuy Pinnacle Trial. The trial was on hold for the Thanksgiving holiday and resumed on November 28. We have not been providing daily updates because most of the recent testimony involved the individual plaintiffs. It was not generalized information applicable to all plaintiffs. There was testimony from the six individual plaintiffs, their family members, and their treating physicians about the health implications of the Pinnacle.

The good news is that we are now at the end of the road. Both sides have rested and closing arguments are scheduled for tomorrow. We will provide an update after closing arguments conclude. We will also provide an analysis and commentary discussing both sides cases. We are hopeful for a verdict in favor of the plaintiffs.

Hi, Stuart Talley here with another update on the DePuy Pinnacle hip trial. Today, I want to talk about the testimony that was provided by one of the defense experts, Dr. John Fisher, an engineer from the University of Leeds, England. He has published many papers on the Pinnacle, MOM hips, and has a large body of publications in scientific literature where he discusses research he did on the MOM hips. On direct examination, the primary purpose was to discuss how these hips are tested and to come to the opinion that the test for the pinnacle MOM hip was adequate.

On cross examination, I would say it was a heated cross. The theme of the plaintiffs in the cross examination of Dr. Fisher was that he really was not an independent academic, which is what he was holding himself out to be. That in reality, he was a paid mouthpiece for DePuy. At one point the plaintiffs' attorney referred to him as a jukebox witness, meaning that you put money in his mouth and he will sing anything you want him to sing.

What was presented at trial was evidence that Dr. Fisher had a series of agreements with DePuy where DePuy agreed to fund research at his University and there were a lot of conditions in the agreement. One condition was that he was not allowed to do any research for competitors. He was also directed as to what kinds of research DePuy wanted him to do and primarily the research would be done to promote DePuy's products. The other condition, which was really surprising, was that DePuy had the right to review any publication or any study that he intended to publish before it was submitted for publication and DePuy would be given the right to propose edits, propose a rebuttal, and in essence a right to respond to anything this academic was going to publish. That is an unusual term in a contract like this because it really takes away from the independence of the doctor.

The other thing presented at trial was evidence that Dr. Fisher was publishing papers in scientific journals and not disclosing the fact that he had this relationship with DePuy. At one point, the doctor admitted that he should have disclosed it with respect to one paper, but there were a series of publications, more than 20 that were presented at the trial where this relationship with not disclosed. There was also testimony and documents presented showing that Dr. Fisher was appearing at academic conferences to talk about his research on the DePuy Pinnacle, ASR and other DePuy products, and that before he made these presentations at these academic conferences, DePuy was reviewing his presentations and sending him emails having him expand on certain topics and those expansions of the topics were designed to undercut DePuy’s competitors, specifically Zimmer. There was some testimony that was presented that basically Dr. Fisher was being used as a mouthpiece for DePuy. At least, that is what the plaintiffs' attorneys were insinuating during the cross examination.

This gets into a real interesting area of medical device litigation and we see this a lot, where you have "supposed" experts or academic who publish papers and there are many situations where these academic have a very close to industry that are not disclosed. And their papers are used by the companies to sell their products. There is also situations we’ve seen in other case, and in this case there will be testimony, about the companies actually writing publications, what we call ghost writing, where they actually write a paper and give it to the doctor, the doctor makes a couple of edits and submits it for publication. This happens a lot in the industry. And it's something that a lot of people in the medical community have been rallying against. There are new rules and regulations about disclosing conflicts of interests, but a lot of that stuff is recent.

The testimony of Dr. Fisher initially was helpful for DePuy, but his credibility was undercut a lot by the cross examination by the plaintiffs' attorney.

Hi, Stuart Talley here doing another update on the ongoing DePuy Pinnacle MOM hip trial. Today, I wanted to talk to about the testimony of Lee Ann Turner. She is a witness who was called by DePuy to testify and she is an engineer that works for DePuy. She was heavily involved in the development of all of the MOM hips that DePuy put out all the way back in 1995 when the process started. On direct exam, she described the sort of history of the development of the Pinnacle hip and discussed in detail all of the testing done on the hip before it was released to the public. The intent from the defense attorney was to sort of counter the argument that the plaintiffs were making that this was a product that was rushed to the market. There was a lot of discussion about the different types of testing done on the device and a very long detailed history was given.

On cross exam, there was significant discussion of the info that DePuy provided to the FDA about this device. Specifically, it had to do with what they call clearance. Clearance is a specification in these MOM hip cases where it basically describes the difference in size of the ball and the cup. So, you have a ball and a cup, and if they are exactly the same size, you’re going to have no clearance. So, the ball has to be slightly smaller than the cup. And, they have done these studies that show that if you have too much clearance, you end up with lots of wear debris. So, you have to tightly control the clearance when you manufacture these devices. And so on cross exam, Ms. Turner admitted that DePuy had given incorrect information to the FDA about the clearance on the Pinnacle MOM hip; that the information given showed a smaller clearance than what was actually submitted. The smaller clearance would indicate less wear versus more wear. Ms. Turner testified that it was a mistake, an insignificant mistake and that it didn’t matter. There were several documents that were presented to her that showed it was more than an insignificant mistake. The FDA found out about the mistake in 2005, so five years later when DePuy tried to get approval for the ASR, in their submission, they said the ASR is just like the pinnacle and cited the clearance, the actual clearance on both hips. And the FDA said, “Whoa, wait a minute, we thought the clearance was something different because of what you submitted back in 2000 on the Pinnacle.” So, the FDA caught them on this error or mistake or however you’d like to describe it. The plaintiffs would describe it as a blatant lie to the FDA to get this product approved. There was also discussion about how the original design had less clearance and they decided to change the clearance the week before they submitted the application to the FDA to get approval. There was testimony that this decision to change the clearance was made only by the engineers. It wasn’t approved or run by the design surgeons who were involved in developing the hip and it was a last second change that was made. Again, I think the theme that the plaintiffs have in this case is that they were rushing this to the market.

With respect to the testing of the device, there was testimony about the types of tests that were run. So what the plaintiffs did on cross examination, was got Ms. Turner to admit that many of the tests that were run involved not the actual Pinnacle MOM hip that was released to the public, but pre cursor designs, different designs, different hips with difference clearance. A lot of the data provided to the FDA about how well this hip had performed in the simulation tests was data involving difference designs, not the actual pinnacle. There was also discussion about a clinical trial that was done. During the direct examination of Ms. Turner, she talked about a test that was done before 2000, where they were actually putting the MOM hips in certain patients and monitoring those patients. They call it an IDE, investigational device exemption. They were doing this study where they were following patients. She indicated that this was a legitimate clinical study. On cross, she admitted that the study was shut down after only two years. The ability of the study to determine to actually determine the biological impact of cobalt and chromium ions on tissue was very limited because most of the time, the problems develop well after two years. So, there was never any effort in that study to follow up patients. They never went back 10-15 years later to see how they did.

​The cross of Ms. Turner has gone very well. The plaintiffs are reinforcing their theme that this product was rushed to the market, that there limited testing done, the testing was done involved different designs, no one really looked at what cobalt and chromium ions would do to people as far as systemic problems as well as problems with tissue and bone destruction. That was never really examined before this product hit the market. Stay tuned. We try to provide these updates as often as we can. It’s difficult because we have a lot to do around here. We are at the point now in the trial where plaintiffs are testifying about their injuries. There is a lot of testimony from doctors and surgeons that treated patients, and a lot is very specific to each plaintiff. We probably will not provide updates on that specific testimony. We will try to stick to the general stuff that impacts every case.

Hi, Stuart Talley here to do an update on the DePuy Pinnacle metal-on-metal hip trial that is currently ongoing in Dallas, Texas. Today, we received an order from the judge discussing what will happen after this trial is finished. It looks like we have about two and a half to three weeks of trial left for the six individual California plaintiffs.

The judge entered an order today setting a date for the next trial which is set to start in September 2017. In his order, the judge indicated that he wanted New York plaintiffs this time. The strategy I believe the judge is implementing here is a strategy of having bellwether trials with groups of plaintiffs from some of the most populous states; New York, Texas and California are the three most populous states. Probably, next we’ll see a group from Florida.

The idea is that when you apply different states laws to the facts and you get verdicts that can provide some guidance to the parties as to what the cases should settle for; at least that’s the idea behind the bellwether trial process.

At this point, DePuy has not made any indication that they want to settle these cases. I think they’re waiting for some more trials to occur and maybe even some decisions from the appellate courts with respect to some of the rulings that the judges made in this case. But at the end of the day there’s going to be a time where they need to resolve these cases. There’s more than 8,000 that are pending. Each time they go to trial, it costs a few millions of dollars to defend the case with attorney’s fees, expert witness fees, etc. It’s a big production every time one of these trials occurs. So, at some point they’re going to have to come to the table. Hopefully, this happens sooner rather than later.

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